Manager overseeing both manufacturing, inspection and research development activities for both Immco and our distributor located in Ontario to ensure systems are compliant with ISO 9001, ISO 13485, 21 CFR 820 and Health Canada. Also overseeing safety activities to ensure compliance with OSHA and WHMIS. Lead representative for all external audits managing audits, reports and corrective actions. Provide approval for all quality documents, including customer notifications. Lead internal and supplier auditor generating annual schedules and assignment of audits. CAPA administrator monitoring completion activities and effectiveness evaluations. Overseeing calibration, maintenance and inspection (incoming and final) activities to ensure customer requirements are meet and product is processed within the validated methods. Provide non-conforming product disposition and root cause analysis to help eliminate future reoccureneces. Provide documentation for product registration in other countries.